Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics

NeuroThera Labs opens Yale site for Phase IIb Tourette trial

SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
The Biotech Times Editorial Team  · 
Biologics

Altimmune begins Phase 3 PERFORMA trial of pemvidutide in MASH

Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
The Biotech Times Editorial Team  · 
Biologics

Dianthus Therapeutics reports 75% CIDP response rate and $1.2bn cash

Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Oblenio Bio doses first patients in LBL-051 autoimmune Phase 1a trial

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The Biotech Times Editorial Team  · 
Biologics

Novo Nordisk raises 2026 guidance as Wegovy pill tops 5m prescriptions

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
The Biotech Times Editorial Team  · 
Biologics

Rein Therapeutics publishes LTI-03 IPF data in Nature Communications

Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
The Biotech Times Editorial Team  · 
Biologics

Syndax posts $73m Q2 revenue as both approved drugs top $200m run rate

Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
The Biotech Times Editorial Team  · 
Biologics

AIM ImmunoTech reaches last-dose milestone early in DURIPANC trial

The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Biotech Times Editorial Team  · 
Biologics

Akebia starts Phase 2 basket trial of complement inhibitor ebribafusp

Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
The Biotech Times Editorial Team  · 
Biologics

Nurix and Roche enrol first patient in Phase 3 bexobrutideg CLL trial

The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The Biotech Times Editorial Team  · 
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The Biotech Times Editorial Team  · 
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
The Biotech Times Editorial Team  · 
Biologics

Amplia Therapeutics publishes narmafotinib pancreatic cancer preprint

A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

AB2 Bio gets $30m as Nippon Shinyaku takes U.S. Tadekinig rights

Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
The Biotech Times Editorial Team  · 
Biologics

Anika Therapeutics raises 2026 guidance after record Q2 revenue

The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
The Biotech Times Editorial Team  · 
Biologics

Atavistik Bio joins Cure HHT network as Harmony-HHT trial opens

Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
The Biotech Times Editorial Team  · 
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